It has been announced today, 27th August, that at this stage the new PAH treatment sotatercept will not be commissioned for use by NHS England.
The decision made by the National Institute of Clinical Excellence (NICE) is based on the evidence that has been presented to them so far, and it is expected they will re-consider based on further submissions.
A consultation period on the draft guidance (the decision) is now in place, closing for comments on 17th September. A second appraisal committee meeting is likely to take place in November.
Whilst this is disappointing news, it is not unexpected. The majority of drug treatments, across all disease areas, receive an initial refusal. In addition, sotatercept is an expensive therapy - considerably higher than every other treatment that is currently available - so this is likely to have been a factor.
We will take the time to fully digest the documents around the decision that have been made available to us as key stakeholders in the process, and we will keep you updated about what comes next.
We have had to fight for every drug that’s currently used to treat pulmonary hypertension, so this isn’t the end. Please be assured that as a patient organisation we will always do everything possible to secure equity of access to therapies that make a difference to people burdened by this disease.
About sotatercept
Sotatercept is a totally new type of drug for pulmonary arterial hypertension. There are already a number of existing drugs that are known as ‘vasodilators’ – which work by opening up some of the arteries that have narrowed or closed down. But these drugs are treating the symptoms of PH, rather than what’s causing the disease.
Rather than just opening up vessels, sotatercept works more directly on the underlying ‘problem proteins’ that are causing the disease in the first place. It’s the first time a PAH drug is getting to the root cause of the problem, rather than treating the consequences of it. It must be remembered though that this is not a cure, so it is not a life-saving drug.
Sotatercept isn’t suitable for everyone. It is designed to be taken by some people alongside other medications, via an injection under the skin administered every three weeks.
It has been announced today, 27th August, that at this stage the new PAH treatment sotatercept will not be commissioned for use by NHS England.
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